Phase Ib/II Trial of Interleukin-2 and PD-1 Checkpoint Inhibitor, Nivolumab In Metastatic Clear Cell Renal Cell Cancer
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|ClinicalTrials.gov Identifier: NCT02989714|
Recruitment Status : Completed
First Posted : December 12, 2016
Results First Posted : March 9, 2020
Last Update Posted : July 13, 2021
This will be a single arm, multi-site phase Ib/II clinical trial of standard doses of High Dose Interleukin-2 (HD IL2) (600,000 IU/kg/dose intravenously during two 5-day cycles 9 days apart) in IL-2 eligible clear cell metastatic RCC (Renal Cell Carcinoma) subjects in combination with Nivolumab.
Investigators hypothesize that concurrent PD-1 inhibition synergistically enhances the anti-tumor immune response to HD IL-2 in metastatic clear cell RCC. Investigators postulate that the combination of the two therapies would result in an increase in the overall response rate, complete response rate, and improved survival outcomes compared to either of the individual therapies.
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma||Drug: Interleukin-2 Drug: Nivolumab||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase Ib/II Trial of Interleukin-2 and PD-1 Checkpoint Inhibitor, Nivolumab In Metastatic Clear Cell Renal Cell Cancer|
|Actual Study Start Date :||March 16, 2017|
|Actual Primary Completion Date :||February 25, 2019|
|Actual Study Completion Date :||June 23, 2020|
|Experimental: HD IL2 and Nivolumab||
600,000 IU/kg/dose intravenously during two 5-day cycles 9 days apart
Other Name: High Dose Interleukin-2
Nivolumab will be administered intravenously at 240 mg/dose over 60 minutes every 14 days, starting 1 week to 3 weeks after the start date of the first cycle of IL2 and continued for up to 48 weeks total in the absence of disease progression
- The Number of Patients With Grade 3 and Grade 4 Adverse Events of Interest [ Time Frame: 28 days from the first dose of Nivolumab ]This is the primary outcome for the Phase Ib portion of the trial. Events of interest are possibly immune-mediated and occur only after at least one dose of Nivolumab has been administered. Immune-mediated events of interest do not include those that are known to occur during high dose IL-2 monotherapy and are reversible. Grade assessed per CTCAE version 4.0.
- The Number of Patients That Respond to Treatment [ Time Frame: 12 Weeks ]This is the primary outcome for the Phase II portion of the trial. Includes complete response (CR) + partial response (PR), measured by computerized tomography (CT) or magnetic resonance imaging (MRI) scan and assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Number of Grade 3-5 Adverse Events of Interest [ Time Frame: For the duration of the therapy plus 60 days post treatment ]Events of interest are possibly immune-mediated and occur only after at least one dose of Nivolumab has been administered. Immune-mediated events of interest do not include those that are known to occur during high dose IL-2 monotherapy and are reversible. Grade assessed per CTCAE version 4.0.
- Overall Survival at 24 Months [ Time Frame: 24 Months ]Overall survival at 24 months following the first dose of study therapy; 24 month estimates were reported using the product limit method of Kaplan and Meier along with 95% confidence intervals.
- Progression Free Survival (PFS) at 24 Months [ Time Frame: 24 Months ]PFS is defined as the time from start of study therapy with Nivolumab until progression or death; up to 24 months. Progressive disease is defined as At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02989714
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109|
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|United States, Ohio|
|University Hospitals Seidman Cancer Center|
|Cleveland, Ohio, United States, 44106|
|Ohio State University|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Ajjai Alva, M.D.||University of Michigan Rogel Cancer Center|